WO2005092278A1 - Compositions de peroxyde stabilisees - Google Patents

Compositions de peroxyde stabilisees Download PDF

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Publication number
WO2005092278A1
WO2005092278A1 PCT/IB2005/000450 IB2005000450W WO2005092278A1 WO 2005092278 A1 WO2005092278 A1 WO 2005092278A1 IB 2005000450 W IB2005000450 W IB 2005000450W WO 2005092278 A1 WO2005092278 A1 WO 2005092278A1
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WO
WIPO (PCT)
Prior art keywords
gum
peroxide
composition according
beaker
water soluble
Prior art date
Application number
PCT/IB2005/000450
Other languages
English (en)
Other versions
WO2005092278A8 (fr
Inventor
Constantine Argy Georgiades
Seema Kirtikumar Mody
Andre Anatoly Soshinsky
Zhen Zhang
Original Assignee
Warner-Lambert Company Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US10/792,370 external-priority patent/US20050196348A1/en
Application filed by Warner-Lambert Company Llc filed Critical Warner-Lambert Company Llc
Priority to AU2005225220A priority Critical patent/AU2005225220A1/en
Priority to AP2006003711A priority patent/AP2006003711A0/xx
Priority to EP05708574A priority patent/EP1732507A1/fr
Priority to JP2007501365A priority patent/JP2007526295A/ja
Priority to CA002557959A priority patent/CA2557959A1/fr
Priority to BRPI0508279-0A priority patent/BRPI0508279A/pt
Publication of WO2005092278A1 publication Critical patent/WO2005092278A1/fr
Priority to NO20063533A priority patent/NO20063533L/no
Priority to IL177265A priority patent/IL177265A0/en
Publication of WO2005092278A8 publication Critical patent/WO2005092278A8/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/22Peroxides; Oxygen; Ozone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73Polysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73Polysaccharides
    • A61K8/732Starch; Amylose; Amylopectin; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/02Local antiseptics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Definitions

  • This invention relates to a stabilized, oral composition, and more particularly, to such composition comprising peroxide compounds.
  • Hydrogen peroxide is a well known antiseptic which has been extensively employed in aqueous solution for the treatment of infectious processes in both human and veterinary topical therapy.
  • the agent can be used in its original form after suitable dilution, or it can be derived from those solid compounds which form salts or additive compounds with hydrogen peroxide. Included among these are sodium perborate, sodium carbonate peroxide, sodium peroxyphosphate, urea peroxide, potassium persulfate, and others.
  • hydrogen peroxide When added to water, these compounds hydrolyze into hydrogen peroxide and the corresponding carrying salt. Although extensively employed for treating all parts of the body, hydrogen peroxide has proved especially valuable for treating the mucous membranes of the oral cavity. Partly as a consequence of oxygen tissue metabolic and reparative requirements (by a mechanism which is not clearly understood), partly as a consequence of its broad antibacterial effects against gram positive and gram negative cocci, bacillus and spirochetal forms as well as many varieties of yeasts and fungi, and partly because of its cleaning and hemostatic effects, hydrogen peroxide is extensively recommended and used for bacterial and viral infections and for tissue inflammations of non-microorganic origin.
  • an aspect of the present invention is to provide improved oral compositions.
  • Another aspect of the present invention is to provide oral compositions providing improved peroxide stability.
  • the present invention relates to oral compositions or solid oral compositions comprising at least two water soluble gums and a peroxide compound wherein the composition, when dried, contains less than about 10% of an hydroalcoholic component.
  • the active, oxygen- generating peroxide component in the composition is stabilized in the oral composition.
  • compositions of the present invention can comprise, consist of, or consist essentially of the essential elements and limitations of the invention described herein, as well any of the additional or optional ingredients, components, or limitations described herein. All percentages, parts and ratios are based upon the total weight of the oral composition of the present invention prior to drying, unless otherwise specified. All such weights as they pertain to listed ingredients are based on the active level and, therefore, do not include carriers or by-products that may be included in commercially available materials, unless otherwise specified.
  • safe and effective amount means an amount of a compound or composition such as a topical or system active sufficient to significantly induce a positive benefit, for example, a teeth whitening, antimicrobial and/or analgesic benefit, including independently the benefits disclosed herein, but low enough to avoid serious side effects, i.e., to provide a reasonable benefit to risk ratio, within the scope of sound judgment of the sldlled artisan.
  • adheresive means any material or composition that is capable of sticking to the site of topical application or administration and includes, but is no limited to, mucoadhesives, pressure-sensitive adhesive (adheres upon application of pressure), moistenable adhesives (adheres in the presence of water) and tachy or sticky type adhesives (adheres upon immediate contact with a surface).
  • foreign substances means dirt, infectious microorganisms and the like.
  • the film compositions of the present invention are clear.
  • the term “clear” as defined herein ranges from transparent to translucent as observed with the naked eye.
  • the film compositions of the present invention, including the essential and optional components thereof, are described in detail hereinafter.
  • compositions of the present invention preferably contain a water-soluble, synthetic or natural gum.
  • Gums suitable for use herein include, but are not limited to algin, alginic acid, alginate salts, camitine, carrageenan, karaya gum, dextrin (starch gum), guar gum, gellan gum, irish moss, veegum (regular), tara gum, o-kra gum, gum arabic, acacia gum, amylopectin, pectina or pecitin, ghatti gum, natto gum, tragacanth gum, xanthan gum, sclerotium gum, kelp, locust bean gum, psyllium seed, tamarind gum, destria gum, chitosan, esters thereof (such as hydroxypropyl chitosan and hydroxypropyl guar), salts thereof (such as ammonium alginate, amylopectin,
  • the water soluble gum can includes xanthan gum (supplied by CP Kelco, Chicago, IL), locust bean gum (supplied by Degussa Texturant System, Atlanta, GA), carrageenan (supplied by FMC Biopolymer, Philadelphia, PA) or mixtures thereof.
  • the water soluble gum When incorporated into the oral compositions of the present invention, the water soluble gum is present at a concentration of from about 0.01% to about 10% optionally, from about 0.1% to about 5% optionally, from about 0.1% to about 1%, and, optionally, from about 0.1% to about 2%, by weight, of the wet film composition.
  • Peroxide Compounds Also incorporated into the compositions of the present invention is a peroxide compound. Suitable peroxide compounds include, but is not limited to, hydrogen peroxide, calcium peroxide, urea peroxide, carbamide peroxide, and mixtures thereof. In certain embodiments, the peroxide is hydrogen peroxide.
  • the effectiveness of peroxide materials can, optionally, be enhanced by means of a catalyst, i.e.
  • the peroxide is present at a concentration of from about 0.1% to about 20%, optionally from about 0.5% to about 15% optionally, from about 1% to about 12%, and, optionally, from about 5% to about 10%, by weight, of the wet film composition.
  • the ratio of the water-soluble gum to the peroxide component is at least about 1:25, optionally, from about 1:25 to about 1:5, optionally, from about 1 :20 to about 1 :7 and, optionally, from about 1 : 16 to about 1:10.
  • Hydroalcoholic component The solid oral compositions of the present invention, when dried, are substantially free of hydroalcoholic components.
  • hydroalcoholic means water or alcohol or mixtures thereof.
  • the compositions of the present invention contain less than 10%) (or about 10%), optionally, less than 6% (or about 6%), and, optionally, less than 3% (or about 3%) of an hydroalcoholic component.
  • actives especially oral care actives
  • the conditions these actives may address include, but are not limited to one or more of, appearance and structural changes to teeth, whitening, stain bleaching, stain removal, plaque removal, tartar removal, cavity prevention and treatment, inflamed and/or bleeding gums, mucosal wounds, lesions, ulcers, aphthous ulcers, cold sores, tooth abscesses, tooth and/or gum pain, tooth sensitivity (e.g. to temperature changes), teeth strengthening and the elimination of mouth malodour resulting from the conditions above and other causes such as microbial proliferation.
  • the films of the present invention are useful for treating and/or preventing wounds, lesions, ulcers, cold sores and the like of the lips and skin generally.
  • Suitable topical actives for use in and around the oral cavity include any substance that is generally considered as safe for use in the oral cavity and that provides a change to the overall health of the oral cavity.
  • the level of topical oral care active in the present invention may generally be from about 0.01% to about 40% or, optionally, from about 0.1% to 20% by weight of the wet film.
  • the topical oral care actives of the present invention may include many of the actives previously disclosed in the art. The following is a non all- inclusive list of oral care actives that may be used in the present invention.
  • Essential oils may be included in or associated with the films the present invention.
  • Additional teeth whitening actives may be included in the oral compositions of the present invention.
  • the additional actives suitable for whitening are selected from the group consisting of metal chlorites, perforates, percarbonates, peroxyacids, and mixtures thereof.
  • Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite and potassium chlorite. Hypochlorite and chlorine dioxide may also be inco ⁇ orated into the compositions of the present invention.
  • a preferred chlorite is sodium chlorite.
  • Anti-tartar agents useful herein include: phosphates.
  • Phosphates include pyrophosphates, polyphosphates, polyphosphonates and mixtures thereof.
  • Pyrophosphates are among the best known for use in dental care products. Pyrophosphate ions delivered to the teeth derive from pyrophosphate salts.
  • the pyrophosphate salts useful in the present compositions include the dialkali metal pyrophosphate salts, tetra-alkali metal pyrophosphate salts, and mixtures thereof.
  • Disodium dihydrogen pyrophosphate Na 2 H P 2 O 7
  • tetrasodium pyrophosphate Na 4 P 2 O
  • tetrapotassium pyrophosphate ?K P 2 0 7
  • Anticalculus phosphates include potassium and sodium pyrophosphates; sodium tripolyphosphate; diphosphonates, such as ethane-1-hydroxy- 1,1-diphosphonate; l-azacycloheptane-l,l-diphosphonate; and linear alkyl diphosphonates; linear carboxylic acids and sodium and zinc citrate.
  • Agents that may be used in place of or in combination with the pyrophosphate salt include materials such as synthetic anionic polymers including polyacrylates and copolymers of maleic anhydride or acid and methyl vinyl ether (e.g. Gantrez, as described, for example, in U.S. Patent 4,627, 977, to Gaffar et al. herein inco ⁇ orated by reference in its entirety, as well as e.g. polyamino propane sulfonic acid (AMPS), zinc citrate trihydrate, polyphosphates (e.g. tripolyphosphate; hexametaphosphate), diphosphonates (e.g.
  • synthetic anionic polymers including polyacrylates and copolymers of maleic anhydride or acid and methyl vinyl ether
  • AMPS polyamino propane sulfonic acid
  • zinc citrate trihydrate e.g. tripolyphosphate; hexametaphosphate
  • diphosphonates e.g.
  • fluoride ion sources inco ⁇ orated into the film compositions as anticaries agents. Fluoride ions are included in many oral care compositions for this pu ⁇ ose, and similarly may be inco ⁇ orated in the invention in the same way. Detailed examples of such fluoride ion sources can be found in US patent 6,121,315 to Nair et al., herein inco ⁇ orated by reference in its entirety. Antimicrobial agents can also be present in the film compositions of the present invention as oral agents or topical skin and/or systemic actives.
  • Such agents may include, but are not limited to, 5-chloro-2-(2,4-dichlorophenoxy)- phenol, commonly referred to as tridosan, chlorhexidine, alexidine, hexetidine, sanguinarine, benzalkonium cliloride, salicylainide, domiphen bromide, cetylpyridium chloride (CPC), tetradecyl pyridinium chloride (TPC); N-tetradecyl-4- ethyl pyridinium cliloride (TDEPC); octenidine; delmopinol, octapinol, and other piperidino derivatives, niacin preparations; zinc/stannous ion agents; and analogs, derivatives and salts of the above antimicrobial agents and mixtures thereof.
  • tridosan chlorhexidine, alexidine, hexetidine, sanguinarine, benzalkonium cliloride, salicylain
  • Anesthetic agent may also be inco ⁇ orated herein.
  • suitable anesthetic agents include, but are not limited to, benzocaine, betoxycaine, biphenamine, bupivacaine, butacaine, dibucaine hydrochloride, dyclonine, lidocaine, mepivacaine, procaine, propanidid, propanocaine, proparacaine, propipocaine, propofol, propoxycaine hydrochloride, pseudococaine, tetracaine hydrochloride and mixtures thereof. Additional useful actives can be found in US patent 6,638,528 herein inco ⁇ orated by reference in its entirety. An additional carrier material may also be added to the oral care film composition.
  • the oral healthcare film may comprise the active substance itself, together with one or more active substance enhancers, for example catalysts and/or potentiators to modify the release and/or activity of the active substance.
  • the film compositions of the invention may, optionally, comprise additional substances such as flavors, colors etc. which may for example be deposited onto the surface of the film or impregnated into the bulk of the film. For example a gel containing additional substances or actives may be deposited directly as a layer on a surface of a film layer.
  • pH adjusting agent may also be added to optimise the storage stability of the gel and to make the substance safe for the oral tissues.
  • pH adjusting agents, or buffers can be any material which is suitable to adjust the pH of the oral care substance. Suitable materials include sodium bicarbonate, sodium phosphate, sodium hydroxide, ammonium hydroxide, sodium stannate, triethanolamine, citric acid, hydrochloric acid, sodium citrate, and combinations thereof.
  • the pH adjusting agents are added in sufficient amounts so as to adjust the pH of the substance or composition to a suitable value, e.g.
  • the pH adjusting agents are generally present in an amount of from about 0.01% to about 15% and preferably from about I 0.05%) to about 5%, by weight of the oral care substance.
  • Methods of depositing active substances mentioned above or additional actives upon the surfaces of film materials are known, for example printing, e.g. silo screen printing, passing between impregnated rollers, dosing, a pump and nozzle, spraying, dipping etc.
  • the film material may be a foam material, particularly an open-cell foam material, and the substance may be impregnated into the strip material by introducing the substance into the cells of the foam.
  • the device of the invention may be marked with one or more visible symbol, e.g. text matter, a trade mark, a company logo, an area of color, or an alignment feature such as a visible line or notch etc. to assist the user in applying the device to the teeth in a proper alignment.
  • Such an alignment feature may for example comprise a symbol to show the user which way up the device should be whilst applying the device to the teeth, or which of a pair of the devices is intended for the upper teeth and which for the lower teeth. This way the device may be made more visually attractive and/or easier to use.
  • symbol(s) may be applied by conventional printing or embossing processes, e.g. silk screen printing, inkjet printing etc. to the surface of the plastically deformable material opposite to the surface on which is attached the layer of an absorbent material. If such a visible symbol is applied to this surface, a cover layer can, optionally, be applied over the symbol, for example to protect it. This cover layer may be transparent or translucent to allow visible symbols to be seen through this layer.
  • Such a cover layer can, optionally, be applied to the film by pressing, e.g. rolling, the material of the cover layer in contact with the film.
  • the film layers of the present application are manufactured using conventional film making technologies such as that disclosed in US patents 6,596,298 to Leung et al. and 6,419,903 to Xu et al., both of which are herein inco ⁇ orated by reference in their entirety. Additionally the film layers of the present invention can be manufactured using hot melt extrusion techniques such as that described in US patent 6,375,963 Bl to Repka et al. herein inco ⁇ orated by reference in their entirety.
  • the present invention can be used where retention of peroxides and additional topical or systemic actives is required for topical activity or adequate systemic abso ⁇ tion.
  • the film compositions of the present invention are particularly useful for whitening tooth surfaces.
  • the delivery of the peroxide, with or without additional actives involves topically applying the inventive film containing a safe and containing effective amount of such compounds/actives to a tooth or teeth and gums in a manner described in US patents 5,894,017; 5,891,453; 6,045,811; and 6,419,906, each of which is herein inco ⁇ orated by reference in its entirety.
  • the frequency of application and the period of use will vary widely depending upon the level of treatment required or desired, e.g., the degree of teeth whitening and/or degree of topical wound healing/disinfection desired.
  • film compositions illustrated in following examples illustrate specific embodiments of the film compositions of the present invention, but are not intended to be limiting thereof. Other modifications can be undertaken by the skilled artisan without departing from the spirit and scope of this invention. All exemplified film compositions can be prepared by conventional formulation and mixing techniques. Component amounts are listed as weight percents and exclude minor materials such as diluents, filler, and so forth. The listed formulations, therefore, comprise the listed components and any minor materials associated with such components.
  • Example I The following is an example of a bi-layer, teeth whitening film of the present invention.
  • Adhesive Layer
  • beaker B The contents of beaker B are mixed into beaker A with rapid mixing or stirring. The combined mixture is mixed until the gums are hydrated. To the combined mixture, the hydrogen peroxide is added slowly with mixing.
  • a separate beaker (beaker C), the flavor, polysorbate 80, glycerin and Atmos 300 are mixed until dissolved and uniform. The contents of beaker C are then poured into beaker A and mixed until the mixture is uniform and homogenous. The pH is then adjusted to about 5.5 using 1.0 N sodium hydroxide.
  • beaker D the pharmaceutical glaze, Cabosil, alcohol and glyceryl sterate is mixed until uniform and homogenous.
  • beaker D is then cast at desired thickness on a non-stick at room temperature to form the inventive film or first layer of the bi-layer, teeth whitening film.
  • the contents of beaker A is then cast at desired thickness over the above- described first layer at room temperature to form the second layer of the bi-layer, teeth whitening film.
  • the thickness of this first or backing layer can optionally range from about
  • any additional layers can equal the range of thickness of the first or backing layer or range from about 30 microns to about 150 microns, optionally from about 45 microns to about 130 microns, optionally from about 70 microns to about 120 microns.
  • Example II The following is an example of a bi-layer, teeth whitening film of the present invention.
  • Adhesive Layer
  • Niscogum BCR 20/80 by Degussa Texturant Systems, Atlanta, GA Supplied under the name Niscarin SD339 by FMC Biopolymer, Philadelphia, PA. Polyvinylpyrrolidone. USP K-90, International Specialties Products(ISP), Wayne, ⁇ J. 5 ALB CG 35% hydrogen peroxide solution, Atofina, Philadelphia, Pa. 6 Supplied under the trade name Splenda®, by McNeil Pharmaceuticals, ? Jew Brunswick, NJ. Tween 80, supplied by Quest, Hoffmann Estates, 111. 8 mixture of mono- a ⁇ id di-oleates supplied under name Atmos 300 by American Ingredients, Kansas City, Mo.
  • the combined mixture is mixed until the gums are hydrated.
  • the hydrogen peroxide is added slowly with mixing.
  • a separate beaker (beaker C)
  • the flavor, polysorbate 80, glycerin and Atmos 300 are mixed until dissolved and uniform.
  • the contents of beaker C are then poured into beaker A and mixed until the mixture is uniform and homogenous.
  • the pH is then adjusted to about 5.5 using 1.0 N sodium hydroxide.
  • the pharmaceutical glaze, Cabosil, alcohol and glyceryl sterate is mixed until uniform and homogenous.
  • beaker D is then cast at desired thic-kness on a non-stick at room temperature to form the inventive film or first layer of the bi-layer, teeth whitening film.
  • the contents of beaker A is then cast at desired thickness over the above- described first layer at room temperature to form the second layer of the bi-layer, teeth whitening film.
  • Example III The following is an example of a bi-layer, teeth whitening film of the present invention.
  • beaker B The contents of beaker B are mixed into beaker A with rapid mixing or stirring. The combined mixture is mixed until the gums are hydrated. To> the combined mixture, the hydrogen peroxide is added slowly with mixing.
  • a separate beaker (beaker C) the flavor, polysorbate 80, glycerin and Atmos 300 are mixed until dissolved and uniform. The contents of beaker C are then poured into beaker A and mixed until the mixture is uniform and homogenous. The pH is then adjusted to about 5.5 using 1.0 N sodium hydroxide.
  • beaker D the pharmaceutical glaze, Cabosil, alcohol and glyceryl sterate is mixed until uniform and homogenous.
  • the combined mixture is mixed until the gums are hydrated.
  • the hydrogen peroxide is added slowly with mixing.
  • a separate beaker (beaker C)
  • the flavor, polysorbate 80, glycerin and Atmos 300 are mixed until dissolved and uniform.
  • the contents of beaker C are then poured into beaker A and mixed until the mixture is uniform and homogenous.
  • the pH is then adjusted to about 5.5 using 1.0 N sodium hydroxide.
  • the pharmaceutical glaze, Cabosil, alcohol and glyceryl sterate is mixed until uniform and homogenous.
  • beaker D is then cast at desired thickness on a non-stick at room temperature to form the inventive film or first layer of the bi-layer, teeth whitening film.
  • the contents of beaker A is then cast at desired thickness over the above- described first layer at room temperature to form the second layer of the bi-layer, teeth whitening film.
  • Example V The following is an example of a bi-layer, teeth whitening film of the present invention.
  • Adhesive Layer
  • a suitable beaker (beaker A), water, sucralose, potassium phosphate monobasic are added with mixing until the mixture is homogenous.
  • a separate beaker (beaker B), xanthan gum, gum arabic, pullulan, and carrageenan are mixed as a dry mix until the mixture is homogenous.
  • the contents of beaker B are mixed into beaker A with rapid mixing or stirring.
  • the combined mixture is mixed until the gums are hydrated.
  • the hydrogen peroxide is added slowly with mixing.
  • a separate beaker (beaker C)
  • the flavor, polysorbate 80, glycerin and Atmos 300 are mixed until dissolved and uniform.
  • beaker C The contents of beaker C are then poured into beaker A and mixed until the mixture is uniform and homogenous. The pH is then adjusted to about 5.5 using 1.0 N sodium hydroxide.
  • beaker D the pharmaceutical glaze, Cabosil, alcohol and glyceryl sterate is mixed until uniform and homogenous. The contents of beaker D is then cast at desired thickness on a non-stick at room temperature to form the inventive film or first layer of the bi-layer, teeth whitening film.
  • beaker A is then cast at desired thickness over the above- described first layer at room temperature to form the second layer of the bi-layer, teeth whitening film.
  • Example V The following is an example of a bi-layer, teeth whitening film of the present invention.
  • a suitable beaker (beaker A), water, sucralose, potassium phosphate monobasic are added with mixing until the mixture is homogenous.
  • a separate beaker (beaker B), xanthan gum, gum arabic, starch, and carrageenan are mixed as a dry mix until the mixture is homogenous.
  • the contents of beaker B are mixed into beaker A with rapid mixing or stirring.
  • the combined mixture is mixed until the gums are hydrated.
  • the hydrogen peroxide is added slowly with mixing.
  • a separate beaker (beaker C)
  • Atmos 300 are mixed until dissolved and uniform.
  • the contents of beaker C are then poured into beaker A and mixed until the mixture is uniform and homogenous.
  • the pH is then adjusted to about 5.5 using 1.0 N sodium hydroxide.
  • the pharmaceutical glaze, Cabosil, alcohol and glyceryl sterate is mixed until uniform and homogenous.
  • the contents of beaker D is then cast at desired thickness on a non-stick at room temperature to form the inventive film or first layer of the bi-layer, teeth whitening film.
  • the contents of beaker A is then cast at desired thickness over the above- described first layer at room temperature to form the second layer of the bi-layer, teeth whitening film.

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Abstract

Cette invention concerne une composition stabilisée destinée à être administrée par voie orale et concerne en particulier une composition comprenant des composés peroxyde.
PCT/IB2005/000450 2004-03-03 2005-02-21 Compositions de peroxyde stabilisees WO2005092278A1 (fr)

Priority Applications (8)

Application Number Priority Date Filing Date Title
AU2005225220A AU2005225220A1 (en) 2004-03-03 2005-02-21 Stabilized peroxide compositions
AP2006003711A AP2006003711A0 (en) 2004-03-03 2005-02-21 Stabilized peroxide compositions
EP05708574A EP1732507A1 (fr) 2004-03-03 2005-02-21 Compositions de peroxyde stabilisees
JP2007501365A JP2007526295A (ja) 2004-03-03 2005-02-21 安定化された過酸化物組成物
CA002557959A CA2557959A1 (fr) 2004-03-03 2005-02-21 Compositions de peroxyde stabilisees
BRPI0508279-0A BRPI0508279A (pt) 2004-03-03 2005-02-21 composições de peróxido estabilizadas
NO20063533A NO20063533L (no) 2004-03-03 2006-08-02 Stabiliserte peroksidmaterialer
IL177265A IL177265A0 (en) 2004-03-03 2006-08-03 Stabilized peroxide compositions

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US10/792,370 US20050196348A1 (en) 2004-03-03 2004-03-03 Stabilized peroxide compositions
US10/792,370 2004-03-03
US11/030,845 US20050196350A1 (en) 2004-03-03 2005-01-07 Stabilized peroxide compositions
US11/030,845 2005-01-07

Publications (2)

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WO2005092278A1 true WO2005092278A1 (fr) 2005-10-06
WO2005092278A8 WO2005092278A8 (fr) 2006-11-02

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EP (1) EP1732507A1 (fr)
JP (1) JP2007526295A (fr)
KR (1) KR20060120270A (fr)
AR (1) AR047828A1 (fr)
AU (1) AU2005225220A1 (fr)
BR (1) BRPI0508279A (fr)
CA (1) CA2557959A1 (fr)
NO (1) NO20063533L (fr)
RU (1) RU2006131558A (fr)
WO (1) WO2005092278A1 (fr)

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Publication number Priority date Publication date Assignee Title
CN101938981A (zh) * 2008-02-08 2011-01-05 高露洁-棕榄公司 组合物和装置
SI25540A (sl) * 2019-01-14 2019-05-31 Tompa Majcen Dominika Formulacije s spojinami aktivnega kisika in pripomočki za njihovo aplikacijo

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0256611A1 (fr) * 1986-08-08 1988-02-24 Squibb Japan Inc. Systèmes d'apport de médicaments oraux
US5718886A (en) * 1996-03-11 1998-02-17 Laclede Professional Products, Inc. Stabilized anhydrous tooth whitening gel
WO1998055044A1 (fr) * 1997-06-06 1998-12-10 The Procter & Gamble Company Dispositif d'administration d'un agent blanchissant pour les dents au moyen d'une bande de matiere dotee d'une faible resistance a la flexion
US20020076384A1 (en) * 2000-09-20 2002-06-20 Orlowski Jan A. Teeth whitening composition in the form of a chewing gum
WO2003015656A2 (fr) * 2001-08-17 2003-02-27 Smithkline Beecham P.L.C. Nouveau dispositif
US20030054034A1 (en) * 1998-09-25 2003-03-20 Sau-Hung Spence Leung Fast dissolving orally consumable films

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0256611A1 (fr) * 1986-08-08 1988-02-24 Squibb Japan Inc. Systèmes d'apport de médicaments oraux
US5718886A (en) * 1996-03-11 1998-02-17 Laclede Professional Products, Inc. Stabilized anhydrous tooth whitening gel
WO1998055044A1 (fr) * 1997-06-06 1998-12-10 The Procter & Gamble Company Dispositif d'administration d'un agent blanchissant pour les dents au moyen d'une bande de matiere dotee d'une faible resistance a la flexion
US20030054034A1 (en) * 1998-09-25 2003-03-20 Sau-Hung Spence Leung Fast dissolving orally consumable films
US20020076384A1 (en) * 2000-09-20 2002-06-20 Orlowski Jan A. Teeth whitening composition in the form of a chewing gum
WO2003015656A2 (fr) * 2001-08-17 2003-02-27 Smithkline Beecham P.L.C. Nouveau dispositif

Also Published As

Publication number Publication date
EP1732507A1 (fr) 2006-12-20
BRPI0508279A (pt) 2007-12-18
JP2007526295A (ja) 2007-09-13
AU2005225220A1 (en) 2005-10-06
WO2005092278A8 (fr) 2006-11-02
CA2557959A1 (fr) 2005-10-06
NO20063533L (no) 2006-08-30
AR047828A1 (es) 2006-02-22
RU2006131558A (ru) 2008-03-10
KR20060120270A (ko) 2006-11-24

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